In 1908 Albert Calmette and Camille Guérin developed the first tuberculosis vaccine. The BCG vaccine is routinely given to infants in many parts of the world today, and is inexpensive — between US 10 cents and 20 cents per dose. However, it has not changed much since the early 20th century and is unreliable in protecting against adult forms of pulmonary TB. Unfortunately, its effectiveness is complicated by the presence of HIV, and TB still causes 5000 deaths per day.
To reach the 2050 Stop TB Partnership goals, new vaccination and prevention strategies are being applied to induce a more efficient immunity than what can be accomplished with BCG alone. The Working Group on new TB Vaccines has a pipeline of candidates consisting of 12 private sector efforts – and two are profiled here.
The leading clinical candidate in the pipeline is MVA85A, sponsored by the Oxford Emergent Tuberculosis Consortium (OETC). OETC has a unique business model structure set up as a joint venture between the University of Oxford and Emergent BioSolutions, a biotech company listed on NYSE. The candidate was out-licensed from the University of Oxford at Phase IIb and current trials are funded by AERAS, a global non-government organization focused on TB vaccines and the Wellcome Trust. The vaccine’s efficacy within HIV+ patients are also being evaluated in Phase IIb proof-of-concept trails in South Africa, Senegal and the Gambia funded by the European and Developing Countries Clinical Trial Partnership (EDCTP). MVA85A is considered a booster vaccine that can be administered post-infection to increase immunotherapy effectiveness.
Halfway across the world is Shanghai H&G Biotechnology, working on another innovative effort. Instead of a prime-boost strategy utilized by OETC, H&G is designing a therapeutic DNA vaccine for the treatment of multi-drug-resistant (MDR)-TB. H&G, unlike all other private sector efforts recorded in the pipeline, is headquartered in a developing country, where TB is a high-priority health problem. It is one of three infectious disease placed high on China’s federal agenda. Subsequently, H&G’s primary funding is obtained from government grants in the 5-year Chinese Strategic Plans. H&G also collaborates intensively with government-sponsored research laboratories and municipal biomedical incubators set up through strong Chinese industrial policy.
It is interesting to compare and contrast these two private sector efforts. Both firms operate in networked partnerships to achieve their clinical milestones. The core firm in both cases is small – each has two full-time employees. Resources are leveraged for the business model from the firm’s external environments and their core partnerships. OETC and H&G operate in different innovation environments, and both have adapted to resource availability surrounding them. The main differences between the firms are the reach of partnerships/strategic alliances and sources of primary funding. OETC could not fund Phase IIb trials alone, and the joint venture enabled matching resource inputs from AERAS and Wellcome Trust. H&G’s partnership structure takes a different approach: the Chinese government is its one dominant resource provider. The Chinese government first set industrial policy to be supportive of centres of excellence and encourages new start-up enterprises to leverage publicly available infrastructure to reach proof-of concept stage and be attractive to private investors.
The science behind TB vaccines is difficult, but entrepreneurial innovators are helping. With innovators participating in the challenge alongside academic laboratories, government and not-for-profit organizations, there is hope of turning the tide against this age-old infectious disease.
 Kaufmann, S., Hussey, G., & Lambert, P.-H. (2010). New vaccines for tuberculosis. The Lancet, 375(9731), 2110-2119.